The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed reddish material and a hole in the pebax.The magnetic and force features were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.The blood found inside the pebax area may contribute to the force issue reported.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no internal action was found during the review.The issue reported by the customer was confirmed.The instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the bwi product analysis lab identified a hole in the pebax.During the procedure, the catheter couldn't be zeroed.A "166" error: 20a pole catheter sensor error, as well as an eeprom error all occurred.The 20a cable to the spu was replaced without resolution.The catheter cable was replaced without resolution.The catheter was replaced, and the issue resolved.The errors are not mdr-reportable.The hole in the pebax is mdr-reportable.
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